Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Participants were enrolled at 97 sites in the United States and 5 sites in Puerto Rico. The first participant was screened on 16 March 2010. The last participant observation for the Week 144 analysis was on 26 June 2013.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

917 participants were screened and 707 were randomized. 700 randomized participants received at least one dose of study medication and comprise the Safety Analysis Set and the Intent-to-Treat (ITT) Analysis Set.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Safety Analysis Set: participants were randomized and received at least one dose of study medication.

The Percentage of Participants With Virologic Success Using the Food and Drug Administration (FDA)-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 Ribonucleic Acid (RNA) < 50 Copies/mL at Week 48

Measure Description

No text entered.

Time Frame

Week 48

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

ITT Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug

The Percentage of Participants With Virologic Success Using the Food and Drug Administration (FDA)-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 Ribonucleic Acid (RNA) < 50 Copies/mL at Week 48
[units: percentage of participants]

87.6

84.1

Statistical Analysis 1 for The Percentage of Participants With Virologic Success Using the Food and Drug Administration (FDA)-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 Ribonucleic Acid (RNA) < 50 Copies/mL at Week 48

Groups [1]

All groups

Non-Inferiority/Equivalence Test [2]

Yes

Difference in response rates [3]

3.6

95.2% Confidence Interval

( -1.6 to 8.8 )

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

The null hypothesis was that the percentage of participants achieving HIV-1 RNA < 50 copies/mL (as defined by the snapshot analysis algorithm) at Week 48 in the Stribild group is at least 12% worse than the response rate in the Atripla group; the alternative hypothesis was that the response rate in the Stribild group is less than 12% worse than that in the Atripla Group.

[2]

Details of power calculation, definition of non-inferiority margin, and other key parameters:

A total of 700 HIV-1 infected participants, randomized in a 1:1 ratio to 2 groups would achieve at least 95% power to establish noninferiority in Week 48 response (HIV-1 RNA < 50 copies/mL per the FDA-defined snapshot analysis) rate difference between the 2 groups. For sample size and power computation, it was assumed that both treatment groups have a response rate of 0.795, a noninferiority margin of 0.12, and that the significance level of the test is at a one-sided, 0.025 level.